- Sumitomo Pharma (Harrisburg, PA)
- …for SMPA investigational and commercial products. The incumbent will provide medical safety support for safety signal management throughout product lifecycle ... strategies and authoring of signal evaluation reports according to established safety governance policies and keeping senior leadership informed of safety… more
- CVS Health (Blue Bell, PA)
- …engagement and drive growth across our Real-World Evidence (RWE) generation, Safety & Surveillance ( pharmacovigilance ) and Clinical Trial Recruitment ... + Serves as a subject matter advocate for CVS Healthspire's, RWE, Safety , and Clinical Trial Recruitment offerings. + Leverages a strong understanding of… more
- Sumitomo Pharma (Harrisburg, PA)
- …with external partners **Key Core Competencies** + Strong understanding of pharmacovigilance regulations and drug safety reporting requirements + Skills ... a dynamic, highly motivated, and experienced individual for the position of Pharmacovigilance Scientist to perform PV activities for assigned programs(s). Ability to… more
- Sanofi Group (Swiftwater, PA)
- **Job Title:** Global Safety Officer **Location:** Swiftwater, PA **About the Job** Are you ready to shape the future of medicine? The race is on to speed up drug ... teams accelerate progress. The GSO is responsible for performing core pharmacovigilance activities, in partnership with PSPV colleagues and cross-functional experts,… more
- Merck (Upper Gwynedd, PA)
- …Our Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines ... and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports,… more
- University of Pennsylvania (Philadelphia, PA)
- …and NIH and NCI mandates. + Play a vital role in performing quality reviews of pharmacovigilance data that are evaluated and acted on by the ACC Data and Safety ... Additional experience in clinical research ie Data Management, Project Management, Drug Safety are a strong plus. The appropriate candidate will possess a thorough… more
- Bausch + Lomb (Harrisburg, PA)
- …Management, Clinical/Medical Affairs, Biometrics, Regulatory Affairs, Quality Assurance, Pharmacovigilance /GPSS and Drug/Device Safety , and Clinical Supplies), ... and provide clinical operations support and guidance for the ongoing surveillance of the safety of patients in clinical trials by reviewing reported AEs and SAEs and… more
- Merck (Philadelphia, PA)
- …management of activities that deliver high quality and timely regulatory and safety submissions for approval. The incumbent will be responsible for translation of ... Drug Development, Employee Training Programs, FDA Regulations, Management Process, Pharmacovigilance , Policy Implementation, Process Improvements, Project Information Management, Project… more
- Pfizer (Collegeville, PA)
- …They work closely with other functions such as regulatory affairs, pharmacovigilance , biostatistics, and medical affairs to ensure that the clinical development ... medical monitoring activities including eligibility assessment, data review and safety monitoring. + Lead peer-to-peer interactions with investigator. + Serve… more
- Sanofi Group (Philadelphia, PA)
- …Development, Regulatory, etc. to facilitate diligence reviews, medical and safety evaluation, product positioning, lifecycle evidence planning, and compliance needs. ... when needed on various types of studies: long-term surveillance, compliance, pharmacovigilance , and effectiveness studies + Maintains awareness of clinical trial… more